Cardiac Safety of Foster & Glycopyrrolate vs Foster in COPD

• Research type

  Research Study

• Full title

  RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP, MULTI-NATIONAL, MULTI-CENTRE STUDY TO EVALUATE THE CARDIAC SAFETY OF TWO DOSES OF GLYCOPYRROLATE BROMIDE (25µG AND 50µG BID) DELIVERED VIA HFA pMDI BOTH COMBINED WITH FOSTER® 100/6µG BID DELIVERED VIA HFA pMDI VERSUS FOSTER® 100/6µG BID DELIVERED VIA HFA pMDI IN PATIENTS WITH MODERATE TO SEVERE COPD

• IRAS ID

  99186

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A

• Eudract number

  2011-004759-37

• Research summary

  The purpose of the present study is to compare the cardiovascular safety of the combination of Foster© 100/6 (daily dose 400/24æg) and Glycopyrrolate Bromide (daily dose 50 or 100 µg) compared to Foster© 100/6 alone (daily dose 400/24 µg) over a 14 day treatment period in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0168

• Date of REC Opinion

  16 Apr 2012

• REC opinion

  Further Information Favourable Opinion